Sr Assembler, Validation

Aliso Viejo, California, USA        ·       Full time

Job ID:11145BR
Job Title: Sr Assembler, Validation
Location: Aliso Viejo, California, USA
1008-China Joint Venture

Job Description

Perform the testing of medical device products in an entry-level position under close supervision from R&D/Manufacturing Technician or Validation Engineer in accordance with test methods.

Job duties:

• Set up test equipment and perform testing of products per test procedures and/or protocols. Examples of test procedures include: Simulated Use test, Instron test, Radial Force test, Burst test, Pouch Seal test, Fatigue test, visual and dimensional inspection, etc.
• Record data associated with the testing of products.
• Communicate with immediate supervisor and/or Subject Matter Experts (SME) when issues related to test materials, equipment, and/or written procedures are encountered.
• Follow all related quality, compliance, and company policies and procedures.
• Understand operations objectives and work with team members to achieve overall test goals.
• Learn and maintain knowledge and skills to perform multiple test procedures successfully.
• As directed by Validation Engineer and/or SME, perform hands-on training to other Assemblers on test procedures.
• Meet all performance standards and metrics by using time and resources efficiently.
• Maintain a safe and clean working environment by keeping work area in a neat and organized manner.
• Must be willing to work overtime when needed.
• Other duties as assigned or required.

Qualifications

• HS diploma or equivalent.
• General knowledge of clean room procedures.
• Previous experience using microscopes.
• Minimum five (5) years of manufacturing/testing experience, preferably in the medical device industry.

Desired Qualifications

• Knowledge of basic measurement tools including scales, rulers, US and metric measurement.
• Ability to work with multiple test equipment and procedures.
• Ability to set up and operate test equipment.
• Ability to read engineering drawings.
• Ability to clearly and effectively communicate with Technicians, Engineers, and Managers.
• Basic math and computer skills (Microsoft Excel, Word).
• Ability to work in a culturally diverse work environment.

Posting Country: US – United States

Please click here to apply.